Peter O‘Blenis, Evidence Partners

EU MDR Compliance: Do Your CERs and PERs Hit the Regulatory Bar?

By Maria Fontanazza
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Peter O‘Blenis, Evidence Partners

MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.

MedTech Intelligence: Briefly explain the importance of clinical evaluation reports (CERs) and performance evaluation reports (PERs) in the context of EU-MDR compliance. What challenges do device manufacturers face in meeting the requirements in this area?

Peter O’Blenis: On paper, a literature review sounds simple, but it’s actually a complex task with a lot of moving parts and opportunities for errors to creep in. Assembling a qualified team is a big challenge. One of the most common problems I see in the EU MDR space right now is the lack of rigor when it comes to the literature review process. Basically, the regulations call for a transparent and reproducible process. If you don’t have a reproducible approach and an audit trail, for example, you really don’t hit that bar. That can hurt you in an audit.

Other issues include data errors. Some organizations were initially using tools like Excel to track data during the review process, but these tools make it easy to introduce errors into the process, and in many cases, it is difficult to detect those errors. If those errors get into your final product, you might find yourself in an expensive situation. We’ve seen software tools help solve this process and help address some of the most common issues faced by organizations. In addition to automating many of the time-consuming aspects of literature reviews, these tools can help manage the entire process—including the references, data, documents, people, and everything involved in the logistical aspects of the literature review. Software can also enforce your protocols, which makes it a lot easier to prevent as well as find data and detect errors. It also makes it easier to expand your literature review team, because they are working in a structured environment that makes it more difficult for them to color outside the lines. Finally, it produces a complete audit trail automatically [so you can] document every single step in a way that allows you to reproduce the entire process.

Peter O‘Blenis, Evidence Partners
Peter O‘Blenis, CEO of Evidence Partners

CERs/ PERs are part of the regulatory landscape in the EU. They serve an important role in ensuring the safety and efficacy of devices sold in that jurisdiction. But for manufacturers, they may represent a whole new set of processes and additional overhead to either bring additional devices to market or even keep them on the market. In addition to new costs, there are other challenges, such as finding qualified people to do the work, or even fully understanding the requirements. Solving the CER/PER puzzle is really critical to manufacturers and many are still sorting it out.

AI [artificial intelligence] also has a lot to offer. And while we have not reached the point where computers do all the work, AI can be pragmatically applied to augment human participation and dramatically accelerate the process, making it faster and much more cost effective than it is using traditional processes. In certain AI applications, you can use it as a second set of eyes, so it is detecting errors that humans have introduced into the process, while still leaving the decision-making power in the hands of a person.

MTI: What evidence-based research hurdles are medtech professionals experiencing as they go through the literature review process? What steps can they take to streamline their workflow?

O’Blenis: One of the biggest issues is that there are not enough people out there who are really good at this and who have the experience and expertise. Many organizations are trying to work it out for themselves, and if you don’t have a structured environment in which to do that—if you’re just using Excel, for example—there’s a lot of rope to hang yourself with. We are seeing organizations reach out and [ask us] how to do these reviews. When you apply a highly structured, software-based process, it can provide the guidance people need to come up to speed much faster than they otherwise would.

Time is an important factor as well. It takes a long time to do a literature review. It looks simple on paper, but logistically it’s very challenging. There’s a lot of data, references, and auditing information on how the process was done. Time to market starts to get impacted. If you can’t get your CERs and PERs approved, you’ll have delays in getting the product on the shelves. Leveraging a software solution that helps manage all of that can save considerable time—upwards of 75% of time saved in some cases.

There are also pragmatic things that create hurdles in the literature review process. Frequently we see people submitting CERs with incomplete data. By incomplete I mean they didn’t review all the references they should have while preparing their CER. Simply put, using conventional methods, the screening process takes a long time. So reviewers intentionally limit their search results to only references that are highly likely to be relevant. By doing this they miss relevant references in their search and run the risk of submitting something [incomplete] to a notified body. Tools that help mediate the amount of time spent on a review means teams can run more comprehensive searches without fear of missing deadlines.

The audit trail is another challenge. You need to have a transparent and reproducible process. If you have not documented every step of the process rigorously, you don’t have a transparent and reproducible process, and that can bite you during an audit. Doing this manually is error-prone and time consuming. Leveraging a tool that tracks every decision and every step of the process for you automatically will help ensure that your process is transparent and reproducible.

MTI: Next month, Evidence Partners is hosting a virtual one-day summit, Evidence Matters 2021, for the literature review community. What are the goals of this event and what do you hope attendees will learn?

About Evidence Matters 2021: The October 19th virtual summit organized by Evidence Partners is expected to bring together the literature review community for a day connecting with thought leaders, learning from real-world stories by industry experts and fostering innovation.O’Blenis: I’m excited about the event, and I think it’s going to be an interesting day. If you take a step back and look at the literature review community as a whole, it [has] become very broad. There are people using literature reviews in health technology assessment, health economics, medical device, CERs, PERs state of the art, in guidelines development, pharmacovigilance and post-market surveillance, and we’re also seeing literature review processes used outside human health and therapeutics, such as in environmental or agricultural. While these applications of the literature review process are significantly distinct, they also have a lot in common. The Evidence Matters ’21 Virtual Summit is an opportunity to gather the diverse literature community to learn and share ideas, and we anticipate an important day of discussing current research, regulatory challenges and exploration of best practices to address these. Speakers include Bassil Akra, Gunther Eysenbach, and David Nash—these guys are leaders in their respective areas. We’ll also hear from key DistillerSR customers in the medical device, HEOR and public sector groups who will contribute to these discussions.

Attendees will have a chance to learn from key players in each of these industries on the challenges faced throughout the literature review process. They’ll probably hear a lot of their own challenges reflected back at them.

Then we’ll go on to explore how automation has streamlined workflows for better outcomes. Innovation sessions will focus on what’s next in automation: AI, intelligent workflows, and the potential for data reuse, all in a literature review context—these technologies are fundamentally changing how we conduct literature reviews, and it’s important to stay on top of it. This is an inclusive event—it’s free, and the entire literature review community is invited: Epidemiologists, librarians, researchers, scientists, government policy makers, and writers. We expect representation from the entire literature review community and that will make it an incredibly rich experience. I’m looking forward to it.

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